BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2792711 · Received October 16, 2012

    Report

    Report Number
    2124215-2012-14008
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 17, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THERE WERE NO ARC MARKS ON THE DEVICE CASE, AND ALL SEAL PLUGS WERE INTACT. THE BATTERY STATUS WAS BEGINNING OF LIFE (BOL) WITH 2.99 VOLTS. RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE CONNECTED TO THE DEVICE AND MANUAL LEAD IMPEDANCE MEASUREMENTS WERE TAKEN. THE RA CHANNEL MEASURED 729 OHMS AND THE RV CHANNEL MEASURED 723 OHMS. THE SHOCK IMPEDANCE WAS TESTED WITH A 50 OHM LOAD MEASURED LESS THAN 20 OHMS, INDICATING A SHORTED CONDITION. A 1.1 JOULE SHOCK WAS DELIVERED INTO AN OPEN/NO LOAD CONDITION IN BOTH INITIAL AND REVERSED POLARITIES AND THE DEVICE RETURNED A SHOCK LEAD IMPEDANCE MEASUREMENT OF OPEN/>125 OHMS IN THE INITIAL POLARITY AND SHORTED/<20 OHMS IN THE REVERSED POLARITY, INDICATING THAT THE DEVICE HIGH POWER OUTPUT CIRCUITRY HAD BEEN DAMAGED WHEN THE DEVICE DELIVERED A 31 JOULE SHOCK INTO A SHORTED LEAD CONDITION ON (B)(4) 2012 DURING EPISODE 174 ATTEMPT #2. THERE WAS NO EVIDENCE OF ARCING NOTED ON THE DEVICE CASE INDICATING THAT THE DEVICE LEAD SYSTEM WAS COMPROMISED AND SHOULD BE TESTED WITH A HIGH ENERGY SHOCK. ENGINEERING ANALYSIS AND EXAMINATION OF THE STORED EGRAM FOR EPISODE 174 ON (B)(4) 2012 DETERMINED THAT THERE WAS MOST LIKELY A RV LEAD ISSUE THAT WAS CAUSING THE NOISY SIGNAL THAT LED TO THE SHOCK, WHICH RESULTED IN THE DEVICE SHOCKING INTO A SHORTED LEAD CONDITION AND THE DEVICE SUSTAINING INDUCED HIGH ENERGY OVERSTRESS DAMAGE TO THE OUTPUT CIRCUITRY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THE PHYSICIAN NOTICED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK AFTER INTERPRETING NOISE AS VENTRICULAR FIBRILLATION (VF) THAT WAS WITHIN THE PROGRAMMED SHOCK THERAPY ZONE. ALSO, THE RIGHT ATRIAL (RA) LEAD (MODEL/SERIAL 4480/(B)(4)) GAVE AN OUT OF RANGE LOW PACING IMPEDANCE MEASUREMENT. THE RIGHT VENTRICULAR DEFIBRILLATION (RV) LEAD (MODEL/SERIAL 0148/(B)(4)) GAVE OUT OF RANGE LOW PACING IMPEDANCE AND SHOCK IMPEDANCE MEASUREMENTS. BOTH THE RA AND RV LEADS EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUT. THE DAILY MEASUREMENTS SHOWED THAT THIS APPEARED FROM (B)(6) 2012. THE PATIENT SAID THAT HE HADN'T CHANGED ANY OF HIS HABITS DURING THAT TIME, AND HAD NOT HAD AN MRI TEST OR CT EXAM. THE PHYSICIAN DID A RADIOSCOPIC EXAM AND IT DIDN'T SHOW ANY DAMAGE ON THE LEADS. A SURGICAL PROCEDURE WAS PERFORMED. THE LEADS WERE TESTED THROUGH A PACING SYSTEM ANALYZER (PSA) AFTER THEY WERE DISCONNECTED FROM THE DEVICE AND THEY EXHIBITED NORMAL THRESHOLD AND IMPEDANCE MEASUREMENTS. THEN, THE LEADS WERE RECONNECTED TO THE DEVICE AND MEASURED AGAIN, AND THE RESULT WAS THAT THEY WERE OUT OF RANGE, AS THEY WERE BEFORE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE, AND THE LEADS WERE CONNECTED. ALL MEASUREMENTS WERE VERY GOOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R